The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
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|ClinicalTrials.gov Identifier: NCT03441997|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Mind-body exercise Other: Light mobility exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||July 17, 2019|
|Estimated Study Completion Date :||December 20, 2019|
Experimental: Full mind-body exercises
Participants will be trained to perform a type of mind-body exercise that involves low intensity exercise and body movements similar to Tai Chi. Participants will be asked to exercise 2 times per day for 8 weeks.
Other: Mind-body exercise
Active Comparator: Light mobility exercises: Control Group
The Light mobility exercises group will perform a similar exercise as the experimental group. However without a few components. Participants will be asked to exercise two times per day for 8 weeks.
Other: Light mobility exercises
Modified mind-body program.
No Intervention: Healthy Controls
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.
- Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10) [ Time Frame: At three time points: before exercise, at the maximum exertion, and 30 minutes after maximum exertion. This procedure will be conducted at baseline and after 8 weeks of qigong/sham-qigong practice. ]Changes will be measured during a bout of exhaustive exercise using a recumbent bicycle machine
- Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention ]Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSIQ), which was designed to differentiate between good and poor sleepers. The PSIQ covers subjective sleep quality, sleep latency, sleep disturbances, sleep duration, daytime dysfunction and use of sleep medications. It consists of 19 self-rated questions. The PSIQ has been vastly employed in clinical trials, and it has been reported to be reliable and valid
- Change in Pressure Pain Threshold (PPT) [ Time Frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention ]Pressure pain threshold is defined as the minimum force applied which induces pain. Mechanical pressure, determined as a kilogram (kg) per 1 cm2 of skin on the sensitive areas, is applied by a Fisher's hand dolorimeter. The examiner places the rubber tip on the examination site and gradually increases the pressure at a rate of approximately 1 kg per second. Subjects are instructed to say ''yes'' when the sensation of pressure causes pain and the pain pressure threshold is recorded. Pain threshold is measured in the 18 points specified by the American College of Rheumatology.
- Change in Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention ]This questionnaire can capture the total spectrum of issues related to FM and the patient's response to therapies. It is one of the most used instrument in trials involving subjects with FM. Also, it has been proven to show consistent response to clinical changes
- Change in Quality of Life evaluated by the Quality of Life Scale (QOLS) [ Time Frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention ]This scale is one of the most used instrument to measure quality of life in patients with chronic disease. The QOLS is a 15-item questionnaire that accesses five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. This scale has been shown to be reliable and validated by previous studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441997
|Contact: Caio Sarmento, PT||(913) email@example.com|
|Contact: Taylor Pfeifer||(913) firstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Caio Sarmento email@example.com|
|Principal Investigator:||Wen Liu, PhD||University of Kansas Medical Center|